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FDA Notice on Trasylol, May 14, 2008
Injuryboard on Trasylol
Injuryboard on Bayer Response to Trasylol studies
Bayer AG on Trasylol
60 Minutes story on Trasylol
New England Journal of Medicine Article
NEJM aprotinin articles
IMAGE SOURCE: ©iStockPhoto/ heart surgery/ miralex
The maker of the recalled drug Trasylol, Bayer AG of Germany, had planned to bring the drug back to the market after the release of a major study. But instead the study is making that less likely.
Last November, Bayer temporarily suspended sales of Trasylol (aprotinin) pending the outcome of a large Canadian clinical trial known as BART.
In October, BART had to be suspended early when data began showing a higher risk of death among patients on Trasylol, given during high-risk heart surgery. The Ottawa Health Research Institute stopped enrolling patients because of ethical concerns.
Now BART's results have been compiled and released in Wednesday's New England Journal of Medicine.
It too confirms earlier findings that Trasylol led to an increase in the chance of death by 54 percent when compared to the other two drugs more commonly used during heart surgery to cut down on excessive bleeding.
Among patients given Trasylol, six percent died within 30 days compared to patients on the standard and less expensive treatments, tranexamic acid or aminocaproic acid.
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